Trial Outcomes & Findings for Study of 0416 Ointment in the Treatment of Atopic Dermatitis (NCT NCT01053247)

NCT ID: NCT01053247

Last Updated: 2014-10-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 793 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2014-10-03

Participant Flow

Participant milestones

Measure	Test Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks	Reference Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.	Vehicle Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks
Overall Study STARTED	269	260	264
Overall Study COMPLETED	249	241	236
Overall Study NOT COMPLETED	20	19	28

Reasons for withdrawal

Measure	Test Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks	Reference Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.	Vehicle Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks
Overall Study Withdrawal by Subject	9	4	15
Overall Study Lack of Efficacy	1	0	1
Overall Study Protocol Violation	2	1	2
Overall Study Lost to Follow-up	8	5	7
Overall Study Adverse Event	0	9	3

Baseline Characteristics

Study of 0416 Ointment in the Treatment of Atopic Dermatitis

Baseline characteristics by cohort

Measure	Test n=269 Participants Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks	Reference n=260 Participants Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.	Vehicle n=264 Participants Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks	Total n=793 Participants Total of all reporting groups
Age, Customized Age	43.0 years STANDARD_DEVIATION 16.29 • n=5 Participants	43.7 years STANDARD_DEVIATION 16.74 • n=7 Participants	43.3 years STANDARD_DEVIATION 17.14 • n=5 Participants	43.3 years STANDARD_DEVIATION 16.70 • n=4 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	158 Participants n=7 Participants	161 Participants n=5 Participants	467 Participants n=4 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	102 Participants n=7 Participants	103 Participants n=5 Participants	326 Participants n=4 Participants
Region of Enrollment United States	258 participants n=5 Participants	253 participants n=7 Participants	255 participants n=5 Participants	766 participants n=4 Participants
Region of Enrollment Central America	11 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	27 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Test n=210 Participants Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks	Reference n=211 Participants Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.	Vehicle n=195 Participants Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment	104 participants	121 participants	67 participants

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome data not reported

Adverse Events

Test

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test n=269 participants at risk Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks	Reference n=260 participants at risk Reference product that contains active pharmaceutical ingredient Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.	Vehicle n=264 participants at risk Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks
General disorders Application Site Irritation	1.1% 3/269	2.3% 6/260	0.00% 0/264
General disorders Application Site Pruritus	0.74% 2/269	3.1% 8/260	1.5% 4/264
Skin and subcutaneous tissue disorders Atopic Dermatitis	0.37% 1/269	0.38% 1/260	1.5% 4/264

Additional Information

Angela C. Kaplan

Fougera Pharmaceuticals Inc

Phone: 631-659-2256

Email: angela.kaplan@sandoz.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER